Important Safety Information Full Prescribing Information
Symproic

For opioid-induced constipation in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation

ELIGIBLE PATIENTS MAY PAY AS LITTLE AS $0* FOR EACH PRESCRIPTION

SYMPROIC PATIENT SAVINGS CARD

Commercially insured patients may be eligible to pay as little as $0*

  • Co-pay amounts may vary—maximum savings is $150 per prescription
  • Patients are responsible for any amount exceeding the maximum benefit of $150 on each prescription
  • Patients whose prescriptions are covered under Medicare, Medicaid, or other government programs are not eligible
  • Cash-paying patients are not eligible

*Maximum savings of $150 per prescription. Restrictions apply.

Please see Eligibility Requirements, and Terms and Conditions below.

For questions, call 844-SYMPROIC (844-796-7764)

Eligibility requirements

This card cannot be used if your prescriptions are covered by: (i) any federal or state healthcare program, including a state medical or pharmaceutical assistance program (Medicare, Medicaid, Medigap, VA, DOD, TRICARE, etc); (ii) Medicare Prescription Drug Program (Part D Program); or (iii) insurance in states that have an “all payor” anti-kickback law or insurance that is paying the entire cost of the prescription. Void where prohibited by law. Patients must meet eligibility requirements. Other restrictions may apply. Cash-paying patients are not eligible.

TERMS AND CONDITIONS

Patients must meet eligibility requirements. Patient agrees to report their use of this card to any third party that reimburses or pays for any part of the prescription price. Patient additionally agrees to not submit any portion of the product dispensed pursuant to this card to a federal or state healthcare program for purposes of counting it toward their out-of-pocket expenses (such as TrOOP under Medicare Part D or Medicaid). This card is not valid with any other program, discount, or incentive involving the covered medication. This offer is good for 13 uses and can only be applied to prescriptions of 20 tablets or more. This offer is not contingent upon any past, present, or future purchases of the covered drug or any other product, and this offer may be rescinded, revoked, or amended without notice. No reproductions. This card is not insurance. This card is void where prohibited or where restricted beyond the terms herein.

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS

A valid prescription must accompany this card at time of first use. Tell your patients to retain their Symproic Savings Card for future savings during the time of offer throughout the program period. Treat these materials like you would a blank prescription pad. Hand them out yourself and don't leave them in the general waiting areas of your office.

The Symproic Savings Card is accepted at participating pharmacies. Certain pharmacies are able to deduct the savings without the Symproic Savings Card. For a list of these pharmacies, go to http://evoucherrx.relayhealth.com/storelookup/.

Please read the Full Prescribing Information. Also, please read the Eligibility Requirements, and Terms and Conditions above.

COVERMYMEDS®

CoverMyMeds partners with electronic health records (EHRs), payers, pharmacies, and providers to initiate, transmit, and track the status of prior authorization (PA) requests within the clinical workflow.

CoverMyMeds technology electronically connects providers, pharmacists, and plan/pharmacy benefit managers (PBMs) to create an ePA solution for all participations.

For more information please visit www.CoverMyMeds.com or call (866) 452-5017.

Corvermymeds

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Includes unrestricted and restricted coverage, preferred and non-preferred coverage.

Inclusion on formulary does not imply superior clinical efficacy or safety.

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Important Safety Information

Contraindications

  • Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction, due to the potential for GI perforation.
  • Patients with a history of a hypersensitivity reaction to Symproic® (naldemedine). Reactions have included bronchospasm and rash.

Warnings and Precautions

Cases of GI perforation have been reported with use of another peripherally acting opioid antagonist in patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract. Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.

Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, increased lacrimation, hot flush/flushing, pyrexia, sneezing, feeling cold, abdominal pain, diarrhea, nausea, and vomiting have occurred in patients treated with Symproic.

Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. Take into account the overall risk-benefit profile when using Symproic in such patients. Monitor for symptoms of opioid withdrawal in such patients.

Drug Interactions

Avoid use with strong CYP3A inducers (e.g., rifampin) because they may reduce the efficacy of Symproic.

Use with moderate (e.g., fluconazole) and strong (e.g., itraconazole) CYP3A inhibitors and P-glycoprotein inhibitors (e.g., cyclosporine) may increase Symproic concentrations. Monitor for potential adverse reactions.

Avoid use of Symproic with another opioid antagonist due to potential for additive effect and increased risk of opioid withdrawal.

Use in Specific Populations

Symproic crosses the placenta and may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier. Symproic should be used during pregnancy only if the potential benefit justifies the potential risk. Because of the potential for serious adverse reactions, including opioid withdrawal in breastfed infants, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Avoid use in patients with severe hepatic impairment. No dose adjustment of Symproic is required in patients with mild or moderate hepatic impairment.

Adverse Reactions

The most common adverse reactions with Symproic as compared to placebo in clinical trials were: abdominal pain (8% vs 2%), diarrhea (7% vs 2%), nausea (4% vs 2%), and gastroenteritis (2% vs  1%).

In pooled Studies 1 and 2, the incidence of adverse reactions of opioid withdrawal was 1% (8/542) for Symproic and 1% (3/546) for placebo. In Study 3 (52-week data), the incidence was 3% (20/621) for Symproic and 1% (9/619) for placebo.

To report suspected Adverse Reactions, contact Shionogi at 1‑800‑849‑9707 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

Indication

Symproic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

Please see Full Prescribing Information and Medication Guide for Symproic.

References: 1. Argoff CE, Brennan MJ, Camilleri M, et al. Consensus recommendations on initiating prescription therapies for opioid-induced constipation. Pain Med. 2015;16(12):2324-2337. 2. Kalso E, Edwards JE, Moore RA, McQuay HJ. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain. 2004;112(3):372-380. 3. Cook SF, Lanza L, Zhou X, et al. Gastrointestinal side effects in chronic opioid users: results from a population-based survey. Aliment Pharmacol Ther. 2008;27(12):1224-1232. 4. Brown RT, Zuelsdorff M, Fleming M. Adverse effects and cognitive function among primary care patients taking opioids for chronic nonmalignant pain. J Opioid Manag. 2006;2(3):137-146. 5. Tuteja AK, Biskupiak J, Stoddard GJ, Lipman AG. Opioid-induced bowel disorders and narcotic bowel syndrome in patients with chronic non-cancer pain. Neurogastroenterol Motil. 2010;22(4):424-e96. 6. Coyne KS, LoCasale RJ, Datto CJ, Sexton CC, Yeomans K, Tack J. Opioid-induced constipation in patients with chronic noncancer pain in the USA, Canada, Germany, and the UK: descriptive analysis of baseline patient-reported outcomes and retrospective chart review. Clinicoecon Outcomes Res. 2014;6:269-281. 7. Emmanuel A, Johnson M, McSkimming P, Dickerson S. Laxatives do not improve symptoms of opioid-induced constipation: results of a patient survey Pain Med. 2017;18(10):1932-1940. doi:10.1093/pm/pnw240 8. Camilleri M, Drossman DA, Becker G, Webster LR, Davies AN, Mawe GM. Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterol Motil. 2014;26(10):1386-1395. 9. Hale M, Wild J, Reddy J, Yamada T, Arjona Ferreira JC. Naldemedine versus placebo for opioid-induced constipation (COMPOSE-1 and COMPOSE-2): two multicentre, phase 3, double-blind, randomised, parallel-group trials. Lancet Gastroenterol Hepatol. 2017;2(8):555-564.